Diamond Pharma Services provided EU regulatory support to Kite Pharma Inc.
'A Diamond does not start out polished and shining, but with enough pressure, hard work and time it becomes brilliant'
Kite Pharma secures breakthrough European positive opinion for CAR-T cell cancer therapy.
On 29th June 2018, Kite Pharma Inc received its positive CHMP opinion for their breakthrough CAR-T cell cancer therapy, YESCARTA®.
The regulatory team within Diamond Pharma Services supported Kite Pharma Inc in all European regulatory activities throughout the development of Kite’s CAR T cell immunotherapy for the treatment of various lymphomas and leukemias, and for the lead lymphoma indications through the submission and Regulatory Authority review of the Marketing Authorization Application. The complexity of the development led to Diamond heavily inputting into the EU strategy, drafting the submissions for successful orphan designation for 6 conditions, the ATMP classification, one of the first PRIME applications, PIPs, IMPDs, advising on SME status and scientific advice needs and coordinating the many clinical trial and GMO submissions across several EU countries.